Food, drugs, devices › Arrow International Inc
Device recall: Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane over 22 Ga. TW Introducer Needle with Integral
FDA enforcement event 84635 is a device recall by Arrow International Inc of Reading, PA, initiated 12 Dec 2019 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 968 device enforcement events initiated in 2019 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Arrow International Inc has 93 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Arrow International Inc, Reading, PA.
Reason for recall
"The lidstock label incorrectly displays a MR (Magnetic Resonance ) Conditional symbol (instead of a MR Unsafe symbol) in reference to a component of the kit"
Distribution
"US distribution to SC"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0844-2020 | Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane over 22 Ga. TW Introducer Needle with Integral .018" (0.46 mm) dia. Spring-Wire Guide Product Code: ASK-04020-PMC The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels. | 80 eaches | Class II | Ongoing | 29 Jan 2020 |
Context
Other enforcement events for Arrow International Inc
All 93 events for Arrow International Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The lidstock label incorrectly displays a MR (Magnetic Resonance ) Conditional symbol (instead of a MR Unsafe symbol) in reference to a component of the kit"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US distribution to SC"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.